FDA 510(k) Application Details - K052965

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K052965
Device Name	Stylet, Catheter
Applicant	GUIDANT CORPORATION 4100 HAMLINE AVE NORTH ST PAUL, MN 55112-5798 US Other 510(k) Applications for this Company
Contact	Linda Kleinsasser Other 510(k) Applications for this Contact
Regulation Number	870.1380   More FDA Info for this Regulation Number
Classification Product Code	DRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2005
Decision Date	02/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review